MIDD: Perspectives and Possibilities

• Activity Number: 17 - Dose Selection and PDUFA VI: Advancing the Model Based Drug Development in Regulatory Environment
• Type: Topic Contributed
• Date/Time: Sunday, July 29, 2018 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Dionne Price*
• Companies: Food and Drug Administration
• Keywords: Model-Informed Drug Development; Dose Selection

Abstract

A goal within the Prescription Drug User Fee Act for fiscal years 2018-2020 (known as PDUFA VI) pertains to the advancement of model-informed drug development. To achieve the goal, the Food and Drug Administration (FDA) is committed to develop the review expertise and capacity, convene a series of workshops, and conduct a pilot program. Overall objectives of the presentation will be to provide a statistical perspective on model informed-drug development (MIDD) and to explore the role of statisticians in enhancing the possibilities associated with MIDD. Since MIDD is a broad term encompassing several quantitative approaches with varying goals, the presentation will begin with an exploration of the taxonomy of MIDD and its relation to the PDUFA VI goals. The presentation will also briefly explore the scientific expertise required to better utilize MIDD for greater impact. Lastly, MIDD efforts within the Center for Drug Evaluation and Research, FDA will be highlighted with a focus on dose selection.